FDA.reportPublic FDA data

Blue Sky Bio, LLC.

Primary DI
00815131026733
Brand
Blue Sky Bio, LLC.
Company
BLUE SKY BIO LLC
Model
Z9814A1
Published
2018-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815131026733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815131026733008151310267338151310267330815131026733

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
618960848
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810060227060Blue Sky Bio, LLCIJHTP30102026-04-22
00810060227077Blue Sky Bio, LLCIJHTP30112026-04-22
00810060227084Blue Sky Bio, LLCIJHTP30132026-04-22
00810060227091Blue Sky Bio, LLCIJHTP30162026-04-22
00810060227107Blue Sky Bio, LLCIJHTP35082026-04-22
00810060227114Blue Sky Bio, LLCIJHTP35102026-04-22
00810060227121Blue Sky Bio, LLCIJHTP35112026-04-22
00810060227138Blue Sky Bio, LLCIJHTP35132026-04-22
00810060227145Blue Sky Bio, LLCIJHTP35162026-04-22
00810060227152Blue Sky Bio, LLCIJHTP43062026-04-22
00810060227169Blue Sky Bio, LLCIJHTP43082026-04-22
00810060227176Blue Sky Bio, LLCIJHTP43102026-04-22
00810060227183Blue Sky Bio, LLCIJHTP43112026-04-22
00810060227190Blue Sky Bio, LLCIJHTP43132026-04-22
00810060227206Blue Sky Bio, LLCIJHTP43162026-04-22
00810060227213Blue Sky Bio, LLCIJHTP50062026-04-22
00810060227220Blue Sky Bio, LLCIJHTP50082026-04-22
00810060227237Blue Sky Bio, LLCIJHTP50102026-04-22
00810060227244Blue Sky Bio, LLCIJHTP50112026-04-22
00810060227251Blue Sky Bio, LLCIJHTP50132026-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EYET38800000K2 MyStains Structure SetYeti Dentalprodukte GmbHEIH2026-05-20
EYET388000010K2 MyStains Structure SetYeti Dentalprodukte GmbHEIH2026-05-20
EYET38800230K2 MyStains ST-S13, uni red, 2g.Yeti Dentalprodukte GmbHEIH2026-05-20
EYET38800240K2 MyStains ST-S14, uni gingiva, 2g.Yeti Dentalprodukte GmbHEIH2026-05-20
EYET38780110K2 Li-Press-Pellets (HT-Hoch Transluzent) B1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780120K2 Li-Press-Pellets (HT-Hoch Transluzent) B1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780210K2 Li-Press-Pellets (HT-Hoch Transluzent) C1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780310K2 Li-Press-Pellets (HT-Hoch Transluzent) BL1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780320K2 Li-Press-Pellets (HT-Hoch Transluzent) BL3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780330K2 Li-Press-Pellets (HT-Hoch Transluzent) BL2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780340K2 Li-Press-Pellets (HT-Hoch Transluzent) BL4, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781010K2 Li-Press-Pellets (LT-Low Transluzent) A1, 5X3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781020K2 Li-Press-Pellets (LT-Low Transluzent) A2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781030K2 Li-Press-Pellets (LT-Low Transluzent) A3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781110K2 Li-Press-Pellets (LT-Low Transluzent) B1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781120K2 Li-Press-Pellets (LT-Low Transluzent) B2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781210K2 Li-Press-Pellets (LT-Low Transluzent) C1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781310K2 Li-Press-Pellets (LT-Low Transluzent) BL1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781320K2 Li-Press-Pellets (LT-Low Transluzent) BL2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781330K2 Li-Press-Pellets (LT-Low Transluzent) BL3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781340K2 Li-Press-Pellets (LT-Low Transluzent) BL4, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38782010K2 Li-Press-Pellets (medium-opak) MO1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780010K2 Li Press-Pellets HT-A1Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38780020K2 Li Press-Pellets HT-A2Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38780030K2 Li-Press-Pellets (HT-Hoch Transluzent) A3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38801100K2 MyStains Structure Body dark, SM-B-D, 2g.Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38760020K2 Li-Mamelon, MM-HO (HONEY), 20g.Yeti Dentalprodukte GmbHEIH2026-05-05
EYET38626150K2-HF OPAQUE DENTIN, OD-D3, 50g.Yeti Dentalprodukte GmbHEIH2026-05-04
EYET38750060K2 Li-Clear, CL, 20g.Yeti Dentalprodukte GmbHEIH2026-05-04
EYET38760010K2 Li-Mamelon, MM-OR (ORANGE), 20g.Yeti Dentalprodukte GmbHEIH2026-05-04